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Transcript of VWHP ,PSOHPHQWDWLRQ *XLGH · program using the SystemSURE Plus within healthcare facilities. ......

SystemSURE PlusATP Cleaning Verification System

System Implementation Guide

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Contents

This guide is designed to assist users in setting up and operating an ATP cleaning verification

program using the SystemSURE Plus within healthcare facilities. For instructions on how to

operate the SystemSURE Plus ATP Cleaning Verification System please reference the

Operators Manual included with the system.

The contents of this guide include:

Section 1: An Overview of ATP Cleaning Verification

1.1 What is ATP? 4

1.2 Measuring ATP with Bioluminescence Technology 4

1.3 Additional Uses of SystemSURE Plus 6

Section 2: Implementing an ATP Cleaning Verification System

2.1 Establishing Test Locations and Limits 7

2.2 Corrective Action Procedures 12

2.3 Suggested Cleaning, Testing, and Corrective Action

Procedure Flowchart 13

2.4 Programming Locations 14

2.5 Setting Up Test Plans 15

2.6 Testing Frequency 16

2.7 Additional Testing 20

2.8 Calibration 21

Section 3: Appendices

Exhibit 1.0: CDC Recommended Test Locations 22

Broad Risk Categories and Limits 23

Proper Sampling Procedure 24

Notes 27

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The SystemSURE Plus ATP Cleaning Verification System

Hygiena’s SystemSURE Plus ATP Cleaning Verification System is a tool used to monitor and

improve the cleanliness levels of surfaces in healthcare facilities. Additionally the system

acts as a tool to educate cleaning staff and other hospital personnel on proper cleaning

techniques for terminal cleaning. The Centers for Disease Control and Prevention (CDC)

encourages all hospitals to develop preventative programs to optimize and monitor the

thoroughness of high touch surface cleaning*. With the SystemSURE Plus ATP Cleaning

Verification System hospitals can standardize the assessment of surface cleaning

throughout one or multiple facilities and monitor cleaning on a continuous basis.

The SystemSURE Plus ATP Cleaning Verification System enables healthcare organizations to:

Instantly assess the cleanliness of surfaces, allowing immediate corrective

action to be taken

Reduce or eliminate variation in surface cleaning performance by standardizing

acceptable cleaning levels

Improve and enhance the training of cleaning personnel

Provide insight into whether current cleaning processes and tools are

sufficient or below adequate

Reduce the use of conventional microbiological testing methods that are

slow, labor intensive, and costly

Record and track test results to identify problem areas, make improvements,

and show due diligence to auditors and compliance with regulations

Enhance environmental cleaning programs which helps to prevent the

spread of harmful bacteria and viruses that are associated with

healthcare associated infections

Ensure patient safety and increase patient satisfaction

Using Hygiena’s SystemSURE Plus Cleaning Verification System, healthcare

facilities are able to create a standard by which to measure cleaning

effectiveness.

*http://www.cdc.gov/HAI/toolkits/Evaluating-Environmental-Cleaning.html

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Components of the SystemSURE Plus ATP Cleaning Verification System

The SystemSURE Plus ATP Cleaning Verification System includes three components:

SystemSURE Plus Luminometer – a user-friendly, handheld, light-reading

unit that provides precise, on-site test results. Used with the UltraSnap

testing device, extremely low levels of contamination can be detected in

just 15 seconds. (Catalog # SS3)

UltraSnap Testing Device – a convenient, all-in-one ATP test device.

Simply swab, snap and squeeze and the test is ready to be measured in the

SystemSURE Plus. Packaged 100 tests per box. (Catalog # US2020)

SureTrend Data Analysis Software – a powerful software program that

allows users to upload test results to

a database, analyze trends and

generate reports for management

and record-keeping. (Catalog #

DS201)

Hygiena’s luminometer, testing

devices and software are designed

to be easy-to-use enabling both

technical and non-technical staff

to operate the SystemSURE Plus.

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Section I: Overview of SystemSURE Plus ATP Cleaning Verification System

The SystemSURE Plus ATP Cleaning Verification System is a rapid cleaning monitoring

system used to help hospitals and other healthcare organizations achieve optimal

standardized cleaning levels. The SystemSURE Plus ATP Cleaning Verification System uses

bioluminescence technology to identify and measure adenosine triphosphate, commonly

known as ATP.

1.1 What is ATP?

ATP is an energy molecule found in all living cells that allows cellular metabolism to take

place. All organic matter contains ATP, including blood, saliva, and bacteria. In healthcare

facilities, organic matter such as bodily fluids, blood and specific bacteria left on surfaces

can become a point of cross contamination between patients and staff leading to

infections if not properly cleaned. Therefore the detection of ATP on a surface after

cleaning is an indication of improper cleaning and that bacteria or bioburden that can

support bacterial growth is still present on the surface.

1.2 Measuring ATP with Bioluminescence Technology

UltraSnap ATP surface tests contain an enzyme called luciferase which produces a

bioluminescence (light-producing) reaction when it comes into contact with ATP. Using

bioluminescence technology, the SystemSURE Plus luminometer can measure low levels

of ATP collected with the UltraSnap test device.

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Measuring the amount of light produced by the ATP reaction provides a good indication of surface cleanliness because the quantity of light generated by the reaction is directly proportional to the amount of ATP present in the sample. The bioluminescence reaction is immediate, allowing results to be processed in real-time. Results are then expressed numerically on the SystemSURE Plus screen as Relative Light Units (RLU).

ATP presence and RLU measured

Clean Dirty

Pas

s

Fail

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1.3 Additional Uses of SystemSURE Plus

In addition to routine ATP cleaning verification in environmental service departments, the

SystemSURE Plus ATP Cleaning Verification System can be used for:

Central/Sterile Services – Used for verifying the cleanliness of flexible endoscopes and other reusable medical devices. Improper cleaning of equipment before sterilization can lead to non-sterile equipment. Food Service/Cafeteria Food Safety – Can be used to verify food preparation surfaces have been cleaned properly. Training – An effective tool for teaching new staff proper cleaning procedures. Hand Hygiene Compliance – Can be used to measure levels of ATP present on personnel’s hands before and after hand washing to demonstrate efficacy and thoroughness of hand washing efforts.

For more information on implementing the SystemSURE Plus in these areas, visit www.hygiena.com/healthcare

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SECTION 2: Implementing an ATP Cleaning Verification System

2.1 Establishing Test Locations and Limits

Before testing begins, it is necessary to identify areas within the facility that will be

tested and establish appropriate Pass/Fail limits for each location. The CDC provides a list

of recommended locations to test in hospitals (see exhibit 1.0 on page 22). Locations

typically tested are high touch point surfaces where the chance of spreading infectious

bacteria is high. Monitoring of low risk surfaces on a less frequent basis is also essential

to verifying the facility is being thoroughly cleaned. Prepare the list of locations on a

piece of paper or Microsoft Excel worksheet. (For a spreadsheet of test locations typical

for health care facilities, contact 1-888-HYGIENA or visit www.hygiena.com)

Once locations to be tested have been identified, Pass/Fail limits for each location can be

established by assigning the locations to broad risk categories (listed on page 23) or by

collecting samples. Before collecting initial samples, it is essential to master proper

sampling procedure as detailed on page 24.

There are three ways to determine custom limits for locations:

1. Standard Deviation Method

Implementation Time: 2-4 weeks

Complexity: Moderate

The SystemSURE Plus comes with a preset Upper Limit of 30 RLU and Lower Limit of

10 RLU. These limits are based on actual limits used in sterile services departments of

healthcare facilities. They are a starting point from which custom limits can be

refined depending on initial results.

Pass <10 RLU

Caution 11-29 RLU

Fail >30 RLU

Over a 2-4 week period sample each location a minimum of 10 times after cleaning. If

locations are the same from room to room, it is acceptable to test the same location

from different rooms. Record RLU measurements on a spreadsheet (Example 1).

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Example 1:

Tests 1 2 3 4 5 6 7 8 9 10

Location RLU measurement

Bedrail 48 49 50 38 38 35 73 118 36 15

IV Pole 10 25 67 35 8 5 50 47 32 24

Bedside Table 45 27 0 2 51 5 0 2 10 6

Remote 112 215 78 45 89 86 95 148 62 71

Panel 0 0 10 9 15 12 0 10 5 5

Once the data points have been collected, Pass/Caution/Fail limits can be customized

for each test location. To determine the lower (Pass) limit of each location, calculate

the average RLU score from the samples collected.

Note: If the average RLU is less than 10, add one standard deviation to the

average. If the average RLU is 0, use system defaults of 10 (pass) and 30 (fail).

To determine the upper (Fail) limit, calculate the standard deviation of the samples

collected and multiply by 3.* Add that value to the average. Statistically, this

calculation indicates with 99.6% confidence that any RLU reading above this level is

an indication of failure to properly clean that area.

(Data from Example 1)

Location Average Ave+ (3 * Standard Deviation)

Bedrail 50 134

IV Pole 30 91

Bedside Table 15 73

Remote 100 248

Panel 7 12** 23

*For calculations using Microsoft Excel:

For lower limit (Pass), use the function “=AVERAGE”

**If Average is below 10, use the function “=STDEV” and add to “=AVERAGE”

For upper limit (Fail) use the function “=3*STDEV and add to “=AVERAGE”

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The range between the Pass and Fail values is the Caution range. Thus, for Example 1

data, the limits for the locations using the standard deviation method are as follows:

Location Pass Caution Fail

Bedrail 50 51-133 134

IV Pole 30 31-90 91

Bedside Table 15 16-72 73

Remote 100 101-247 248

Panel 12 13-22 23

This option could give different Pass, Caution and Fail levels for each location. This is

typical when different surface types (plastic, stainless steel, etc) are being tested and

when the age of equipment varies.

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2. Band Method

Implementation Time: 2-4 weeks

Complexity: Moderate

The Band Method categorizes results into different limit bands.

Band Pass Caution Fail

4 150 151-299 300

3 100 101-199 200

2 50 51-99 100

1 25 26-49 50

Collect results the same way as in the Standard Deviation method (see page 7).

To determine the band that is most appropriate for the test point, calculate where

80% of the results fall.

E.g. if 80% or more of the results collected for a given test point are below 100 RLU,

band 3 would be the appropriate band for this location. Here is an example applying

results from Example 1.

Location Total Samples

<150 Band 4

<100 Band 3

<50 Band 2

<25 Band 1

Bedrail 10 100% 90% 70% 10%

IV Pole 10 100% 100% 80% 40%

Bedside Table 10 100% 100% 90% 70%

Remote 10 90% 70% 10% 0%

Panel 10 100% 100% 100% 100%

Test Points Band

Bedrail 3

IV Pole 2

Bedside Table 2

Remote 4

Panel 1

Overall (Average) 2

1111

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2. Simple Clean Method

Implementation Time: 1-2 days

Complexity: Easy

With this method, the manager overseeing the ATP cleaning verification program

should clean each location that will be tested the way the manager wants the

location to be cleaned each time. Ten samples should be taken from the same

locations in different rooms to ensure that no site is tested more than once. For

example, the light switches in ten different rooms could be sampled after the

cleaning of these sites. Testing the same location, but in different rooms is

acceptable. Input the results into the Standard Deviation Method to calculate upper

and lower limits for each location (see page 7).

If the average for a location is “0 RLU” then the limits should be set to the system

defaults of 10 RLU for Pass and 30 RLU for Fail. Occasionally blank UltraSnap devices

may emit up to 2 RLU of naturally occurring light. A pass limit of 10 RLU is a

reasonable sensitivity for hospital surfaces and equipment.

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2.2 Corrective Action Procedures

Corrective action procedures provide clear instructions for what steps should be taken

following Pass, Caution, or Fail results.

Recommended corrective action procedures are as follows:

ATP TEST RESULT CORRECTIVE ACTION

(Pass)

The surface has been adequately cleaned.

(Caution)

The surface may not have been adequately cleaned. You

may choose to proceed to the next test or have the area

re-cleaned and re-tested. A control point with a Caution

reading should be noted and monitored for future

problems.

(Fail)

The surface has not been cleaned to the cleaning standard

and must be cleaned again and re-tested.

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2.3 Suggested Cleaning, Testing, and Corrective Action Procedure Flowchart

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2.4 Programming Location Pass/Fail Limits into Software

Once the locations have been identified and the limits determined, they must be entered into

the SureTrend software and synced with the SystemSURE Plus luminometer.

For instructions on how to install SureTrend software and add locations see the installation

guide and manual included with the SureTrend CD. See section 8.3 in the SureTrend User

Manual for steps on entering locations and limits.

If you would like assistance programming locations and limits in the SureTrend software,

please contact your Hygiena representative.

By default the SureTrend software assigns a Lower limit of 10 and an Upper limit of 30 when

you add a new location. Assign the correct limits to each location based on the processes

used in Section 2.1.

Group information can also be entered at this time. Group information is used for grouping

locations together for reporting purposes. For example, groups can allow users to compare

the performance of departments, wings, or facilities.

Below is an example of the location setup in SureTrend software.

Prog # Location Group Lower Upper

1 Bedrail – East St. Jude - East 50 100

2 Remote Control - East St. Jude – East 25 50

3 Sink – East St. Jude - East 15 30

4 Bedrail - West St. Jude – West 50 100

5 Remote Control - West St. Jude – West 25 50

6 Sink - West St. Jude - West 15 30

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2.5 Setting Up Test Plans

Once location and limits have been input into SureTrend software, test plans may then be

set up. See section 8.4 in the SureTrend Users Manual for steps on setting up Test Plans.

Test Plans are groups of locations that are tested one after each other, grouped together, or

tested on a specific day.

Here are some examples of test plans:

Public areas

Handrails

Door levers

Waiting area chair

Telephone

Water cooler

Nurses’ Station

Keyboard

Phone

Countertop

File cabinet handle

Light switch

ICU Patient Room

Ventilator control panel

IV Pole

Monitor cables

Call button

Door handle

ER Mobile Workstations

Crash cart

ECG cart

Laceration cart

Bedside cart

Trauma cart

IV cart

IV medication cart

Cast cart

Monday

Bedrails

IV Pole

Bedside Table

Remote

Panels

West Wing Patient Room

Bed tray table

Patient phone

Call button

Bed rail

Main light switch

Sink handles

Toilet flush handle

Bathroom light switch

Bathroom handrail

Television remote

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2.6 Testing Frequency

Once test plans are programmed into the SureTrend software, SystemSURE Plus may be

synced with the software and testing may begin. The frequency of testing will be

determined by:

Budget

Size of facility

Importance of the cleaning standard

Logistical and staff constraints

Compliance with CDC environmental monitoring recommendations or other auditing

bodies’ recommendations

The CDC has a recommended formulation for sample size determination. It is broken out in

two segments: Baseline Monitoring and Ongoing Monitoring

1. Baseline Monitoring

This is the initial testing regiment that should be conducted to accurately assess the

current level of cleanliness and compliance to the current cleaning processes. This

initial testing will become the baseline to gauge improvements or deterioration of the

thoroughness of cleaning and determine the number of points which must be

monitored on a regular basis.

While it would be ideal to identify small fluctuations in practice accurately (e.g., 10%

relative change), such an approach takes slightly more time and testing. Instead, a

meaningful change in cleaning practice (e.g., 20% relative change) can be detected

without having to evaluate a substantial number of surfaces. The CDC recommends

sampling all available surfaces identified in Section 2.1 or Exhibit 1.0 (page 22) in a 10-

15% sample of representative patient rooms in hospitals with over 150 beds. In

hospitals with less than 150 beds, all available surfaces should be tested in a

minimum of 15 rooms for a baseline and ongoing monitoring.

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The following is an example of a baseline evaluation (to measure levels of

cleanliness):

For a 250 bed hospital with 10 locations in each room, 100 OR locations, and 100

equipment and sterile services locations, there are 2700 total locations to be tested.

To monitor 10-15% of locations, a total of 270-405 locations will need to be tested

three times per year (a total of 810-1215 tests per year).

Hospital A Patient

Room

Locations

OR

Locations

Equipment

& Sterile

Service

Locations

Total

Locations to

be Tested

Total Tests per Year (3

baseline evaluations

per year)

250 Rooms 2,500* 100 100 2,700

10% 250 10 10 270 810

15% 375 15 15 405 1,215

*10 locations per room x 250 rooms = 2,500

The CDC recommends baseline monitoring is conducted at least three times per year.

This is the minimum amount of testing that can be done to show a 20% relative

change in cleaning levels. If pass levels decline, then more testing should be done in

order to determine what is causing deterioration. (i.e. inefficient sanitizer, insufficient

cleaning process, poor employee performance, etc).

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2. Ongoing Monitoring

When hospitals have achieved more than 80% or higher pass results from routine

testing, the number of surfaces to be monitored can be decreased to those available

in a 5% sample of rooms per evaluation cycle unless there is deterioration in practice.

The following is an example of ongoing monitoring (once 80% or more of test results

are “Passing”):

For a 250 bed hospital with 10 locations in each room, 100 OR locations, and 100

equipment and sterile services locations, there are 2700 total locations to be tested.

To monitor 5% of locations, a total of 135 locations will need to be tested three times

per year (a total of 405 tests per year).

Hospital A Patient

Room

Locations

OR

Locations

Equipment &

Sterile

Service

Locations

Total

Locations to

be Tested

Total Tests

(3 times per

year)

250 Rooms 2,500* 100 100 2,700

5% 125 5 5 135 405

*10 locations per room x 250 rooms = 2,500

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Daily Monitoring

More and more hospitals are moving to daily or monthly ATP cleaning verification.

Daily monitoring only requires a few tests per day, yet holds cleaning staff

accountable for achieving an optimal level of cleanliness each and every day.

Creating a rewards system based on daily results can be a very powerful program

that brings staff together and improves overall hospital cleanliness.

Daily monitoring does take more time and requires more consumables, so a hospital

should make sure this type of testing is within resources and budget. Below is a chart

breaking down the time and consumable use associated with a daily ATP cleaning

program in a 250 bed hospital.

Total Test

Locations to

Monitor in the

Hospital

Test to do

Daily

Total Time to

Take Tests (1

minute per

Test)

Test per

Month (30

days)

Total Time

Allotted For

Testing per

Month

Test per

Year

Total Time

Allotted

per Year

2,700 5 5 minutes per

day

150 2.5 hours 1,800 30 hours

2,700 10 10 minutes

per day

300 5 hours 3,600 60 hours

2,700 15 15 minutes

per day

450 7.5 hours 5,400 90 hours

Source: CDC Toolkit for Evaluating Environmental Cleaning, Appendix C,

http://www.cdc.gov/HAI/toolkits/Appendices-Evaluating-Environ-Cleaning.html

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2.7 Additional Testing

ATP cleaning verification can also be integrated into a hospital’s emergency cleaning

procedures as a final step to confirm thorough cleanliness.

In the event of patient accidents, bio-waste spills, flood, new construction, outbreak, or other

accidental contaminations involving blood, urine, or fecal waste, cleaning staff should

perform an emergency cleaning of that area. To confirm thorough cleaning of the site, an

ATP test can be taken. This will ensure that the spill site has been properly cleaned.

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2.8 Calibration

To verify instrument calibration, Hygiena offers two calibration kits that are recommended

for periodic use with your SystemSURE Plus System.

Calibration Control Rod Kit (Catalog# PCD4000)

It is recommended that calibration of the SystemSURE Plus

luminometer is verified with the Calibration Control Kit once a

month for audit record-keeping purposes. Incorporating the

Calibration Control Kit into a cleaning verification program will

confirm that the instrument is within specifications and operating

correctly.

Each kit contains a positive rod and negative rod. The positive rod

emits a very low level of constant light output that can be

measured in RLUs to verify proper calibration of the unit. The

negative rod produces zero (0) RLU and is used to check that

background light is not entering the instrument, while ensuring that

the light detector is calibrating correctly. The Calibration Control

Rod Kit is good for five years of repeated use.

Positive Control Kit (Catalog # CK25)

The Positive Control Kit is used for

validating the efficacy and quality of the

UltraSnap ATP Testing Device. It comes

with 25 sealed glass vials, each of which

contain a certain amount (approx. 5 x 10-

13 moles) of freeze-dried ATP and sugars to

provide a predictable result if UltraSnap

devices are used and stored correctly.

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Exhibit 1.0 CDC Recommended Test Locations

High Touch Objects:

Bed control

Phone and call button

Chair

Light switch

Sink top

Flush handle

TV remote

Toilet Area:

Sinks

Bathroom light switch

Door knobs and levers

Bathroom handrails

Toilet seat

Toilet handles

Bed pan cleaning equipment

Patient Area:

Bed rails

Tray table

Call boxes

Telephones

Bedside tables

Patient chair

IV Pole

Where applicable:

IV pump control panel

Monitor control panel

Monitor touch screen

Monitor cables

Ventilator control panel

Mobile workstations (carts)

For an expanded list of recommended testing locations for health care facilities, contact

Hygiena at 1.888.HYGIENA or visit www.hygiena.com

* Source: CDC Environmental Checklist 10-28-2010 available at

http://www.cdc.gov/HAI/toolkits/Environmental-Cleaning-Checklist-10-6-2010.pdf

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Broad Risk Categories and Limits

These general guideline limits are based on samples collected from hospital wards. Facilities

that do not wish to establish custom limits (page 7) may assign these general limits to the

appropriate testing locations.

Application General Recommended Limits Pass (RLU) Fail (RLU)

Hospital public areas

Examples:

Elevator call buttons Hallway handrails Waiting room areas

<60 >80

Near patient areas

Examples:

Call button Bed rails Patient restroom Monitor panels IV pole

<25 >50

Sterile services

<10 >30

Washer disinfector <5 >10

Food preparation and catering <10 >30

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Proper Sampling Procedure

The SystemSURE Plus luminometer is designed to detect contamination that cannot be seen

by the naked eye. Before collecting a sample for testing, the surface should be visibly clean.

If any soiling or residue is apparent, re-clean the area before testing.

1. Turn on the SystemSURE Plus luminometer. The system will run

through a 60 second automatic calibration. Once calibration is

complete, scroll through the program numbers (PROG) to find the

programmed test location that correlates to the location being tested.

This action should be taken prior to swabbing.

2. Remove the individual UltraSnap device from the package. Next, remove the outer tube by holding onto the double ring base of the Snap-Valve while pulling down on the tube. The swab tip comes pre-moistened. Condensation may be visible on the inside of the swab tube. This is normal. Do not touch the swab tip or shaft with fingers or anything else, as this will contaminate the test. Discard any swabs that accidentally get tainted or activated.

3. NOTE: For optimal performance, swabs that have been removed from cold storage should stand for 10 minutes at room temperature before use.

4. Collect a sample with the UltraSnap device using the guidelines below. The UltraSnap

device is designed to detect trace amounts of contamination. An excessive amount of sample may interfere with the bioluminescence reaction and produce an inaccurate test result, which is why it is important to remove all visible soil from a surface before swabbing.

a. Regular surfaces: Swab a 10 x 10 cm (4 x 4 in) square on the test surface. Rotate the swab as the sample is collected, while applying firm pressure. This will create a slight bend in the swab shaft.

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b. Irregular surfaces: Where 10 x 10 cm square sampling is not

feasible, swab as much of the surface as possible. Be sure that a slight bend in the shaft is achieved and an adequate sample is collected. Note: Consistent sampling pattern on irregular surfaces is necessary to ensure reliable and repeatable results. All individuals responsible for performing swab tests should agree on similar sampling pattern.

5. Re-insert the swab into the tube. UltraSnap is now ready to be activated, or it can be left inactive for up to 4 hours in this state.

6. Holding the device upright, activate the UltraSnap by bending the bulb at the top until the plastic Snap-Valve breaks, then bend once more in the opposite direction. Squeeze the bulb twice to expel the liquid-stable reagent contained in the bulb and allow it to flow to the bottom of the tube.

7. Gently shake the device with a side-to-side motion for 5-10 seconds, bathing the swab bud in the liquid-stable reagent. The test is now activated and the bioluminescence reaction is taking place. For optimal results, the reading should be taken on the SystemSURE Plus luminometer within 60 seconds of activation.

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8. Open the lid on the SystemSURE Plus luminometer, and insert the activated UltraSnap device into the reading chamber. Close the lid, making sure to keep the machine upright for an accurate reading.

9. Continuing to hold the unit upright, press “OK” on the SystemSURE Plus to initiate measurement. Results are displayed on the screen in 15 seconds.

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For additional information or support, please contact us:

USA941 Avenida AcasoCamarillo, CA [email protected]

InternationalUnit 11 Wenta Business CentreColne Way, Watford, HertfordshireWD24 7 ND, UK+44(0)1923 [email protected]

ChinaNeiwailaing Building Suite 21A3No. 518 Shangcheng RoadPudong New District, Shanghai, [email protected]

www.hygiena.com